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Colloidal GoldInfectious Disease Test KitH. Pylori Antigen Rapid Test Kit

SKU: IVD testing kits 20,H. Pylori Antigen Rapid test Kit

Product Name: HP stool antigen test kit, H.pylori Antigen Test Infectious Diseases, One Step H Pylori Rapid Test Kits, HP Helicobacter Pylori Antigen Test

Sample type: Stool

Detection type: Qualitative

Method: Colloidal Gold Rapid Test

Function: Diagnose

Certificate: ISO9001/ ISO13485/CE/NMPA

Format: Cassette, Strip, Uncut Sheet

Sensitivity: 93.9%

Specificity: 97.3%

Total Accuracy : 96.4%

Reading time : 

Observe the result in 15 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Description

H. Pylori Antigen Rapid Test Kit (Colloidal Gold) for the qualitative detection of H. Pylori Antigen in faeces.

 

1.Product Description:

The NewScen H. pylori Antigen Rapid Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimens. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.

The NewScen H. Pylori Antigen Rapid Test Kit is for the detection of H. Pylori Antigen (HPAg) in human faeces.

H. Pylori Antigen Rapid test Kit

 

2.Principle:

The NewScen H. Pylori Antigen Rapid Test Kit uses double antibody sandwich method and colloidal gold immunoassay, which uses nitrocellulose filter membrane coated with HP antibody, colloidal gold-labeled HP antibody, and other reagents. When the test is performed, if the sample is positive, the HP antigen in the sample can bind to the gold-labeled HP antibody to form a complex. As the complex moves forward along the test strip by chromatography, it will then bind to the antibody coated by the test line to form the gold-labeled antibody ~HP antigen ~ antibody compound and agglutinate for color display.

There is a quality control line on the nitrocellulose filter membrane as the control, so when there is a red quality control line and a red reaction line, it is positive. When there is no HPAg in the sample to be tested only a red quality control line is negative.

 

3.Storage:

The NewScen H. Pylori Antigen Rapid Test Kit should be stored at room temperature (4-30°C, do not freeze) for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible (within 1 hour) to avoid the test cassette from becoming moist. Do not use the test beyond the indicated expiration date.

The diluent buffer should be stored at room temperature (4-30°C, do not freeze).

 

4.Sample Collection And Test Preparation:

4.1. The samples should be fresh. If the samples cannot be tested immediately, they can be stored for 1-2 days at 2~8°C and 3 months in -20°C.

4.2. Randomly collect samples in a clean, dry container.

4.3. Unscrew the cap of the sample collection and take the collection stick out. Be careful not to spill the solution out of the bottle

4.4. A random sampling at several different locations on the sample with a sample collection stick (or 20~50mg of feces with a sample collection).

4.5. If the sample is a diarrhea-like fluid sample, can absorb about 50 μL of samples for testing.

 

5.Procedure of NewScen HPAG Rapid Test  Kit:

H. Pylori Antigen Rapid test Kit

5.1. Insert the sample collection stick into the sample collection tube, tighten the cap, and shake it vigorously to ensure the sample and solution are well mixed.

5.2. Tear off the pouch to take out the detection reagent, take off the cap of the sample collection tube, and add 2~3 drops (80~100 μL) of sample liquid into the sample hole of the detection cassette.

5.3. Observe the result in 15 minutes.

 

6.Result Interpretation:

H. pylori Ag Rapid Test CE

6.1. Negative: No red lines appear in the test zone (T) in 15 minutes only a red line show in the control zone (C), indicates that no HPAg have been detected with this test. However, this does not exclude the possibility from infection with H. Pylori.

6.2. Positive: One red line show in the control zone (C) and one red line in the test zone (T). It indicates the specimen infect H. Pylori possibly, recommend further testing.

6.3. Invalid: No red lines appear in the control zone (C), regardless of whether there is a red line in the test zone (T), indicating that the test is invalid. Discard the test cassette and perform with new cassette.

 

Built-In Control

The kit has a built-in procedural control that demonstrates assay validity. If a red line appeared in the control zone (C), it indicates that the test runs correctly.